The purpose of the study is to determine efficacy and safety of combination therapy with adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)

Adequate renal function: renal function (Creatinine clearance > 50mL/min), based on Cockroff - Gault. In case Creatinine clearance is < 50 ml/min, a test in urine will be done in 24 hours and if the value is > 50 ml/min, the patient could be eligible for the study

Potential fertile women negative pregnancy test in serum or urine, 10 days prior the first study dose given

Use an adequate contraceptive method (postmenopausal women should be amenorrheic at least 12 months previous the study to be considered as not potentially fertile (VN:upper limit on normal laboratory values)

Exclusion Criteria:

non measurable lesion as only disease evidence

previous chemotherapy treatment for advance disease. It wont´t be consider as exclusion criteria if chemo or radiotherapy has been given for localized disease and finished more than 1 year ago. In caso os only measurable disease in the radiated area, progressive disease has to be documented previous to the inclusion

active infectious process ((leukocytes superior to 12 x 109/l or fever upper to 38º, it is required thorax X:ray, hemoculture and urine culture 5 days previous to the inclusion)

severe or bad controlled concomitant disease

neoplastic history (except skin basocellular or in-situ cervical carcinoma properly treated) in the last 5 years

patients with any other medical or surgical important problem that, in the investigator opinion, could not allow to follow the treatment

not able to fulfill the protocol and follow-up

being involve in any investigational trial with any drug within 4 weeks prior the study treatment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733616

Locations

Spain

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, Spain

Sponsors and Collaborators

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Sanofi

Hoffmann-La Roche

Investigators

Study Chair:

Fernando Rivera, MD; phD

Hospital Marques de Valdecilla. Santander. Spain

More Information

No publications provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)